The safety of a medical device called an IVC filter is coming into question, even as its clinical use is increasing. A new study released in September 2016 has concluded that there is “no significant difference” in survival of trauma patients who receive a filter versus those who do not, and unless the devices are removed when no longer necessary, they may actually be causing harm when left in the body.
What Does IVC Mean?
The inferior vena cava, or IVC, is the largest vein in the human body. After blood is pumped from your heart and circulated through your body to deliver nutrients and oxygen, the two vena cava veins are the vessels that carry the depleted blood back to your heart again. The superior vena cava delivers blood from just the head and arm areas. The inferior vena cava delivers blood from the entire rest of the body.
What Does an IVC Filter Do?
When someone is at great risk of blood clots in their lower extremities, whether due to injury, illness, immobility, or another factor, there is a danger that the blood clot could break free of its location and travel through the body, pass through the heart, and lodge in the arteries of the lungs. When this happens, it causes an extremely dangerous condition called pulmonary embolism, which is an emergency condition that can be fatal. The signs of an embolism include:
- Suddenly becoming short of breath
- Chest pain made worse by breathing or coughing
- Coughing up frothy and pink (blood-laced) mucus
- Fever and sweating
- Fast, irregular heartbeat
- Swelling or pain in the leg or calf
- Blue discoloration (cyanosis) of the skin
The IVC filter itself is a small wire cage-like device that is implanted into the IVC near where it connects to the heart, and is designed to catch blood clots. IVC filters are often given to patients who cannot, for medical reasons, take anticoagulant drugs that would normally prevent clots from forming. When the filter stops a clot before it can cause damage to the heart and lungs, the body’s own defenses (possibly aided by medication) will slowly dissolve it, preventing severe illness and death.
What Did the September 2016 Study Say?
The study, published in JAMA Surgery, looked at patients who received IVC filters after trauma versus those who did not. Nearly 800 patient records were examined. Researchers concluded that for those patients who survived beyond 24 hours, chances of survival were not significantly affected by the filter at all.
Worse was the discovery that merely around eight percent of filters were ever removed from patients at all. Long-term IVC filter placement is known to have risks, including:
- Perforation, when a part of the device punctures the IVC or other tissue
- Filter migration, when the device moves from its intended location
- Filter fracture, when the device breaks
- Deep Vein Thrombosis (DVT), causing dangerous clots to form
With so many risks, but so few apparent benefits, you may not be surprised to learn that lawsuits are being filed against manufacturers.
IVC Filter Lawsuits Against Cook Medical and C.R. Bard
Two manufacturers of IVC filters in particular are being held accountable by patients across the nation. C.R. Bard, makers of such products as the Bard Recovery filter, Bard G2, and Bard G2 Express filters, are alleged to have hidden internal test results which showed that the filter was prone to failure, including fracture and perforation. The Bard Recovery was recalled in 2005, and over 1,000 lawsuits claiming negligence, breach of warranty, manufacturing defects, and other charges have been filed to date. The court consolidated these into a complex Multi-District Litigation (MDL) case in 2015.
Cook Medical, makers of the Cook Celect and Cook Gunther Tulip filters, is similarly on the hook. An MDL has been formed of nearly 1,000 cases, and bellwether trials are scheduled to begin in 2017.
Get Legal Help Now
If you’ve been harmed by an IVC filter, you may be eligible to receive compensation. At Wayne Wright LLP, we know what you’ve gone through—we’ve seen it so many times, and our compassion is with you. We would like to do what’s right and stand up in a court of law for you to make sure that you get what you’re owed by these greedy device manufacturers. To talk to an experienced attorney, call us today for a free consultation at 800-237-3334.